Kornimate/medical-research-clean huggingface dataset:
tear production by nasal neurostimulation compared to active control

Conditions: Dry Eye; Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: this crossover design study evaluates the effectiveness of the oculeve intranasal neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the jones schirmer test in participants with dry eye disease.

in this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at visit 2 (day 1). at visits 3 (day 15) and 4 (day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. the schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. tear meniscus height (tmh) and, to a lesser extent, tear meniscus area (tma) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (ded). one reliable means of measuring tmh and tma is via use of optical coherence tomography (oct), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. due to the non-invasive nature of the technique, this study was designed to explore the utility of tmh and tma captured by oct as a means of evaluating stimulated tear production following use of the study device.

Eligibility criteria:
inclusion criteria: * mild to severe dry eye disease * have not worn contact lenses for at least seven days prior to the screening visit and willing to forego the use of contact lenses for the duration of the study * literate, able to speak english or spanish, and able to complete questionnaires independently exclusion criteria: * previously used the intranasal neurostimulator at any time * used commercial lid hygiene product within 14 days of the screening visit or plan to use at any time during the study * chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding * nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas * severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the screening visit * have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator * participation in any clinical trial with a new active substance or a new device within 30 days of the screening visit

Keywords: dry eye disease
study of the safety and efficacy of rgh-896 in patients with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: this study is designed to evaluate the safety and efficacy of rgh-896 in patients with diabetic peripheral neuropathic pain.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 to 75 years of age * a diagnosis of painful diabetic neuropathy * controlled blood glucose * willingness to wash out all analgesic medications used for dpnp * female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception * female patients who are not pregnant exclusion criteria: * acute infections or cardiac problems * past use of pregabalin * history of severe psychiatric disorder * history of any amputation due to diabetes * history of seizure disorder * active diabetic foot ulcers

Keywords: diabetic peripheral neuropathic pain chronic diabetes
treatment of vasomotor symptoms in korean post menopausal women

Conditions: Vasomotor Symptoms

Summary: study to demonstrate that the therapeutic efficacy of angeliq® is better than placebo in korean postmenopausal women with hot flushes and other climacteric symptoms. safety and tolerability of angeliq.


Eligibility criteria:
inclusion criteria: * postmenopausal korean women suffering from hot flushes exclusion criteria: * standard exclusion criteria for hrt clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

Keywords: vasomotor symptoms vasomotor system
pulsed electromagnetic fields for postoperative pain: a linical trial in humans

Conditions: Pain; Oral Surgery; Third Molar Extraction

Summary: this randomized clinical trial was designed to assess the clinical efficacy of pulsed electromagnetic field pemf delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction. the sample included 120 patients undergoing unilateral mandibular third molar extraction. the devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. all patients were asked to record pain (on a visual analog scale \[vas\]), hours of wearing the device (groups t and p), and any use of analgesics. at 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

introduction: pulsed electromagnetic field (pemf) therapy is a noninvasive method for delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema. this randomized clinical trial was designed to assess the clinical efficacy of pemf delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction. materials and methods: the sample included 120 patients undergoing unilateral mandibular third molar extraction. at the end of the surgical procedure, patients were randomly assigned to a test (t) or placebo (p) group and fitted with enabled or disabled pemf devices, respectively, or to a control (c) group not fitted with a pemf device. the devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. all patients were asked to record pain (on a visual analog scale \[vas\]), hours of wearing the device (groups t and p), and any use of analgesics. at 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

Eligibility criteria:
inclusion criteria: * patients who needs third molar extraction, * good oral hygiene, * no contraindications to treatment. exclusion criteria: * age under 14 years; * poor oral hygiene (plaque index less then 20%); * contraindications for surgery (or anesthesia); * infectious or systemic diseases; * immunosuppressant therapy; * pregnancy or breastfeeding; * mental disorders.

Keywords: pulsed electromagnetic fields post operative morbidity third molar extraction pain
study of ide397 in participants with solid tumors harboring mtap deletion

Conditions: Solid Tumor

Summary: this is a phase 1, open-label, multicenter, dose escalation and expansion study of the safety, pk, pd, and preliminary anti-tumor activity of ide397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (sg), in adult patients with selected advanced or metastatic mtap-deleted advanced solid tumors who are unresponsive to standard of care therapy. ide397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (mat2a).


Eligibility criteria:
inclusion criteria: * participant must be at least 18 years of age * advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy * have evidence of homozygous loss of mtap or mtap deletion * willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. exceptions may be made for feasibility and safety concerns * measurable disease * ecog performance status \<= 1 * adequate organ function * able to swallow and retain orally administered study treatment * recovery from acute effects of prior therapy * able to comply with contraceptive/barrier requirements exclusion criteria: * known symptomatic brain metastases * known primary cns malignancy * current active liver or biliary disease * impairment of gastrointestinal (gi) function * active uncontrolled infection * clinically significant cardiac abnormalities * previous treatment with a mat2a inhibitor and / or prmt inhibitor or sacituzumab govitecan * systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry * radiation therapy within 2 weeks prior to study entry * prior irradiation to \>25% of the bone marrow * current use or anticipated need for food or drugs that are known strong cyp3a4/5 inhibitors or inducers * currently receiving another investigational study drug. * known or suspected hypersensitivity to ide397/excipients or components

Keywords: mat2a 9p21 cdkn2a mtap solid tumors prmt5 sam synthetic lethality inhibitor mtap deletion cdkn2a deletion mat2a inhibitor advanced solid tumors lung cancer bladder cancer squamous nsclc urothelial cancer non small cell docetaxel paclitaxel sacituzumab govitecan trodelvy
bern, get ready (beready) cohort study for pandemic preparedness

Conditions: Pandemic, COVID-19; Infections; Zoonoses; Epidemic Disease; Respiratory Tract Infections

Summary: the beready project aims to find out how people in the canton of bern can be helped to be more prepared for the next pandemic. beready wants to understand how infections spread among people as well as between people and animals. beready wants to find out how social and environmental factors can influence the transmission or catching of infectious diseases. beready wants to better understand how households and their pets in the canton of bern were and continue to be affected by the coronavirus disease 2019 (covid-19).

the overall aim is to establish beready as a 'pandemic preparedness cohort', a cohort with a well-characterised study population of households, which has an infrastructure to conduct studies about infectious diseases, and which can be rapidly mobilised to respond to a new pandemic. beready aims to understand the epidemiology and transmission of infectious diseases (particularly viral respiratory pathogens) in households including pets in the canton of bern, and to engage diverse communities in efforts to strengthen pandemic preparedness. the objectives are: * to study the distribution and timing of infectious diseases and transmission patterns of circulating infectious diseases, both between individuals and at the human-animal interface (one health) * to study social (e.g. gender, affective polarisation) and environmental factors (e.g. climate change), which may affect transmission or acquisition of infectious diseases; * to understand how households, including their pets, in the canton of bern have been and will be affected by covid-19; and * to engage diverse communities in ongoing efforts to strengthen pandemic and public health literacy, and to prepare for the public health response to a new pandemic.

Eligibility criteria:
inclusion criteria for adults and children: * informed consent * residence (average of more than 3 days/week) in a private household in the canton of bern where at least one member aged 18 agreed to take part. * for adults, children aged 14 years or older, and parents/legal guardians: internet connection (wi-fi, fixed or on a mobile phone) and personal email address. * for adults, children aged 11 years or older, and parents/legal guardians: able to understand, speak, read and write german, french and/or english. inclusion criteria for household pets: pets of eligible household members with the consent of their owners. exclusion criteria for adults and children: currently planned move outside the canton of bern

Keywords: one health pandemic preparedness community engagement
temporary epicardial cardiac resynchronisation.

Conditions: Cardiac Failure

Summary: this trial will investigate the clinical and haemodynamic effects of temporary biventricular pacing after cardiac surgery. subjects with poor left ventricular systolic function will receive either temporary biventricular pacing or 'standard' post-operative pacing for 48 hours. the investigators hypothesis that reversal of cardiac dyssynchrony will improve tissue perfusion and cardiac haemodynamics after surgical revascularisation. this will shorten post-operative recovery in cardiac itu.

patients with poor left ventricular (lv) function are at higher risk of complications after cardiac surgery, compared to patients with preserved lv function. the higher complication rates also lead to prolonged cardiac intensive care (citu) admissions for monitoring and multi-organ support. the investigators hypothesise that biv pacing will reverse cardiac dyssynchrony and improve target organ perfusion. this will be significantly reduced the post operative requirement for level 3 citu care. this study will compare 48 hours of temporary biventricular (biv) pacing to enhance cardiac function against standard post-operative pacing, in patients with poor lv function undergoing cardiac surgery. temporary biventricular (biv) pacing will be achieved with the addition of a third pacing electrode attached to the left ventricle. using a pulmonary arterial catheter the interventricular (vv) delay will be adjusted to yield the maximum cardiac output at constant heart rate- sequential biv pacing. a pilot study conducted at the university hospital of wales (uhw) showed that this approach is likely to be successful. the primary endpoint of the study will be the mean duration of level 3 citu care required by patients after cardiac surgery. secondary endpoints will include: haemodynamic improvement with biv pacing; post-operative renal function; atrial fibrillation (af)/ ventricular arrhythmias; post operative inotropic requirements and changes in biomarkers- nt pro bnp and troponin t.

Eligibility criteria:
inclusion criteria: * coronary disease scheduled for surgical revascularisation. ejection fraction \<35% (simpson's method.) exclusion criteria: * permanent pacemaker or implantable defibrillator. dialysis dependent renal failure. permanent atrial fibrillation.

Keywords: cardiac failure thoracic surgery cardiac pacing, artificial
ablative radiotherapy to consolidate maximal systemic response in metastatic prostate cancer (anchor-prostate)

Conditions: Prostate Cancer Metastatic

Summary: a phase iir cmrct trial companion to pera registry, investigating the merit of sabr consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental sabr based on psma-pet detected disease after maximal systemic response. the primary endpoint is the rate of ffs at 1 year. patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.


Eligibility criteria:
inclusion criteria: 3.1.1 enrolled in pera (chum cer 17.032) and randomly selected for anchor-prostate. 3.1.2 diagnosis of metastatic prostate cancer having achieved maximum psa response to soc systemic therapy defined as two consecutive stable psa within 6 months of regimen start. stable psa is defined as non- progressing (\<25% rise from nadir, per pcwg3 guidelines). 3.1.3 ecog 0-2 3.1.4 psa \> 0.2 ng/ml 3.1.5 1-5 sites of psma-pet avid disease amenable to sabr. exclusion criteria: * none
identification of allergen-reactive antibodies in the blood of pollen allergic patients

Conditions: Pollen Allergy

Summary: the project examines the hypothesis that monoclonal allergen-neutralizing antibodies can be recombinantly produced from b lymphocytes isolated from pollen allergic patients. patient samples suitable for antibody cloning are selected based on seroprofiling for the respective allergens. the study aims at isolating lymphocytes from patients with potential allergen-neutralizing igg in serum and to clone antibodies from antibody gene sequences obtained from b cells of those patients.


Eligibility criteria:
inclusion criteria: * history of allergic rhinitis, conjunctivitis or asthma due to sensitization to grass- or birch allergens * male or female patients older than 18 years * written informed consent for providing blood and also to allow experimental manipulation exclusion criteria: * age \< 18 years * any corticosteroids within the last three days * oral corticosteroid therapy within the last ten days * parenteral depot corticosteroids within the last three months
hypopressive effectiveness in postural control and pelvic floor.

Conditions: Pelvic Floor Disorders; Postural; Defect; Muscle Weakness

Summary: effects of an exercise program based on hypopressive exercises in the female population.

participants allocated to the intervention group completed 10 weeks of hypopressive exercises training with a frequency of two sessions of 30 minutes twice a week.

Eligibility criteria:
inclusion criteria: * women * physical autonomy exclusion criteria: * vestibular disorders. * coronary diseases. * recent surgery.
a study to assess efficay and safety of lc350189 different doses in gout patients with hyperuricemia

Conditions: Gout; Hyperuricemia

Summary: the aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of lc350189 in subjects with hyperuricemia and a diagnosis of gout.


Eligibility criteria:
inclusion criteria: 1. subjects or the subject's legally acceptable representatives who sign a written informed consent form prior to the initiation of any study procedures. 2. subjects with hyperuricemia and a history or presence of gout per american college of rheumatology (acr) criteria. exclusion criteria: 1. subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant). 2. subjects experiencing an active acute gout attack within 3 weeks prior to screening (visit 1).
an open label study of a peptide vaccine in patients with stage iib or iiia non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasm

Summary: ep2101 is a new cancer vaccine containing 10 different peptide antigens. the vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. this study will test the safety and measure the level of immune stimulating capability of ep2101 in patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of non-small cell lung cancer, stage iib or iiia * at least four weeks following prior standard treatment, with no evidence of disease * must use adequate birth control exclusion criteria: * prior cancer vaccine therapy or concurrent participation in any other investigational study * a history of hiv, hepatitis b or c, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment * a history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine * women who are pregnant, intend to become pregnant, or who are breast feeding

Keywords: vaccine lung cancer carcinoma, large cell non-small-cell lung carcinoma
study of immune response in obesity and type 2 diabetes

Conditions: Obesity; Type 2 Diabetes; Healthy Volunteers

Summary: there is a link between activation of the immune response inducing chronic inflammation and both obesity and type 2 diabetes. to date, however, the cause(s) of this inflammation, the mechanisms of the inflammatory cascade and the type of cells involved are not completely known. the aim of our project is to study the principal cell types involved in the immune response from a quantitative and functional point of view in obese diabetic patients versus obese non-diabetic patients and healthy subjects who are neither diabetic nor obese. despite possible inter-individual heterogeneity of immune cells, the fact that this work will be carried out by an accredited team with considerable expertise in the study of almost all the different types of immune cells will probably make it possible to know whether cell dysfunction and inflammation are associated with obesity or rather linked to insulin resistance. this study will be completed later by a second study on cell infiltration in adipose tissues in the 3 groups defined above. better understanding of the physiopathology and especially the mechanisms and type of cells involved in obesity-related inflammation could quickly lead to the development of appropriate therapies that could act specifically on the cells involved and thus preclude the onset of complications.


Eligibility criteria:
inclusion criteria: * patient-control who have given written informed consent patient-control who are covered by the national health insurance agency patient-control \> 18 years old the criteria to classify patients into groups will be as follows: group 1- obese diabetics bmi \> 30 kg /m2 and fasting glycemia \> 1.26 g/l and triglycerides \>1.5g/l and hdl \ 30 kg /m2 and fasting glycemia \ 0.4g/l (men), \>0.5g/l (women) group 3- healthy subjects bmi \< 25 kg/m² and fasting glycemia \< 1.10g/l and triglycerides \<1.5g/l exclusion criteria: * persons not covered by the national health insurance agency patients who presented a recent infection, or cancer or patients treated with corticosteroids or anti-inflammatory drugs. patients with diabetes following an overload disease (hemochromatosis) or due to a disease of the pancreas chronic infection pregnant women patients on the following treatments (glitazone: actos, avendia; glp1 agonist: byetta, victoza; fibrates) patients presenting severe renal insufficiency with clearance\<30ml/min

Keywords: obese patients obese patients with type 2 diabetes healthy volunteers
upper airway function and cardiorespiratory performance in impair trunk motor control multiple sclerosis patients.

Conditions: Multiple Sclerosis

Summary: multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. it is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. the aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * have a diagnosis of ms in any of its forms according to mcdonald criteria * were aged higher than 18 years * no pathology in the uppers extremities * capacity to understand and response the questionnaires * ability to provide informed consent. exclusion criteria: * cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate * inability to provide informed consent.
bladder suture in uterus-sparing surgery and hysterectomy for placenta percreta

Conditions: Placenta Percreta; Bladder Injury; Sutures

Summary: this study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. this evaluation focuses on cases where bladder dissection and acar-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy.


Eligibility criteria:
inclusion criteria: * pregnant women * clinical diagnosis of pas * pas with bladder invasion exclusion criteria: * cases with incomplete or inadequate medical records * cases with other types of placental invasion (e.g., placenta accreta, placenta increta), * cases with missing key data points.

Keywords: placenta percreta, bladder invasion, sutures